1. Field of the Invention
This invention relates generally to devices that are used in connection with catheters and, specifically, to membranous shrouds or envelopes that are employed to cloak a catheter in order to facilitate sterile (aseptic) insertion of such into a bodily passage. The shroud, or envelope, of the present invention eclipses the extant art by combining with it an integral, yet detachable, container element.
2. Discussion of Relevant Art
There exists in the field a need for an apparatus that will allow a medical professional to aseptically catheterize and withdraw a clean urine specimen from a patient, or allow one limited physically, say by paraplegia, to perform self catheterization and void the bladder, either fully or partially (e.g., taking a specimen sample). Although art exists that will allow aseptic or sterile catheterization and uncontaminated fluid collection/containment serially, there does not exist a combination of shroud, i.e., a sterile barrier interposable between the catheter and wall of the body passage being penetrated, and the containment element, so that these activities might be accomplished simultaneously with a unitary/singular device and under sterile conditions. The absence of such a combination does not deter medical providers so much that it hinders self-collection by those having physical limitations (ibid).
A consideration of the relevant art must begin with my U.S. Pat. No. 3,421,509 ('509), for an URETHRAL CATHETER that discloses a catheter which has inserted in its distal end (i.e., with respect to the user, who manipulates the device from its proximal end) a membranous (tubular) envelope that is extractable out of the catheter, as its distal end is advanced into the urethra. To facilitate withdrawal of the envelope, I provide an annular sleeve and guard portion, much like a collar, to slide over the catheter and which is attached to a hem of the envelope. As the catheter advances (forward) into the urethra, the sleeve is urged rearward, towards the catheter's proximal end, by manipulation or by contact against the glans/urethral orifice, and the envelope is extracted. The envelope, or shroud, of this invention does not include an integral container, but is made to engage with and connect to a pouch via the rear end of the guard portion. Such an arrangement necessitates use of an introducer element, which is non-integral to the envelope or the pouch.
Another sheathed catheter is disclosed in U.S. Pat. No. 4,652,259 ('259), entitled CATHETER ASSEMBLY. This disclosure shows a catheter disposed within an outer sheath, the outer sheath composed of two co-linear tubular members. A containment feature, providing a flexible shroud, is in reality a sterile covering that encloses the juncture of the two tubular members. Thus, its function is to maintain sterile conditions within the sheath proper and is not a container, in the conventional sense. Also relevant to the instant invention is U.S. Pat. No. 5,531,717 ('717) for NON-CONTAMINATING PROBE AND METHODS OF MAKING AND USING SAME, a sheathed catheter assembly. This patent discloses an annular collar that is attached to a hem of a sheath member and is provided in order to allow the user to manipulate (the extraction of) the sheath. However, a series of drawings in the disclosure reveal that the collar is an adjunctive construct, and not integral to the sheath. My more recent patent, U.S. Pat. No. 5,792,114 ('114), for INTRODUCER FOR STERILE INSERTION OF CATHETER, also employs a non-integral collar. The envelope (termed "shroud") therein is distinctive over the envelopes or sheaths of the aforementioned patents in that it has only one open end; but, the closed end, although possessing a small cavity, cannot be said to contain an integral fluid receptor/collector. Furthermore, the integrity of this closed-end design is violated by the operational introduction of the catheter.